THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
Report
- Report Number
- 9614641-2023-00286
- Event Type
- Malfunction
- Date Received
- March 2, 2023
- Date of Event
- October 11, 2022
- Report Date
- June 2, 2023
- Manufacturer
- AOMORI OLYMPUS CO., LTD.
- Product Code
- GEI
- UDI-DI
- 04953170383540
- PMA / PMN Number
- K211838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS EVENT FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO D9, THE CORRECT DATE IS 14-APRIL-2023. CORRECTION TO H4, INFORMATION WAS INADVERTENTLY NOT INCLUDED ON THE PREVIOUS SUPPLEMENTAL MEDWATCH. THE DEVICE WAS RETURNED AND AN EVALUATION WAS COMPLETED FOR IT. DURING INSPECTION, OLYMPUS CONFIRMED THE REPORTED EVENT, THE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY AND A PART OF THE TISSUE PAD WAS PEELED AWAY. ADDITIONALLY, THE COATING OF THE GRASPING SECTION WAS PARTIALLY PEELED OFF AND THE COATING OF THE PROBE WAS PARTIALLY PEELING; HOWEVER, THESE DEFECTS ARE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, THE FOLLOWING STEP-BY-STEP SCENARIO LIKELY CAUSED THE EVENT: THE TISSUE PAD WAS WORN AWAY BECAUSE NO TISSUE WAS BEING GRASPED BETWEEN THE GRASPING SECTION AND THE PROBE TIP WHEN THE DEVICE WAS ACTIVATED OUTPUT IN SEAL & CUT MODE FOR/AFTER A TRANSECTION OF TISSUE. THE TISSUE PAD WAS EXCESSIVELY HEATED DUE TO FRICTION BETWEEN THE GRASPING SECTION AND THE PROBE TIP. THIS CAUSED THE TISSUE PAD TO BE PARTIALLY PEELED AWAY. THE FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ¿DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING.¿. ¿WHEN CUTTING AND VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM IT IS TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE TISSUE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN TISSUE PAD AND THE PROBE TIP DURING ACTIVATION.¿. ¿IF THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT OR THE PROBE TIP GETS STICKED TISSUE DURING TREATMENT, WIPE IT WITH A SOFT OBJECT SUCH AS A PIECE OF GAUZE OR A BRUSH. DO NOT ATTEMPT TO SCRAPE IT WITH A SHARP OBJECT SUCH AS A SCALPEL OR THE TIP OF TWEEZERS. OTHERWISE, THE GRASPING SECTION, METAL-EXPOSED AREA AROUND IT, THE FLUORINE RESIN PART, A COATED SURFACE OR THE PROBE TIP MAY BE SCRATCHED AND DAMAGED, WHICH MAY LEAD TO FALL-OFF OF THE DAMAGED PART INTO THE BODY CAVITY OR BURNS OF THE TISSUE BY A HIGH-FREQUENCY LEAK CURRENT OUTPUT DUE TO DESTRUCTION OF THE INSULATION STRUCTURE.¿. OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.
DEVICE HAS BEEN RETURNED. THERE IS A CORRECTION OF THE DEVICE LOT NUMBER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: D4, D9, G3, G6, H2, AND H10.
CUSTOMER REPORTED FOUR THUNDERBEAT DEVICES THAT FAILED WITH DETACHED TISSUE PADS ON THE SAME DAY. THESE EVENTS ARE CAPTURED IN MEDWATCHES WITH PATIENT IDENTIFIERS (B)(6)(TB-0535FCS, KR239789), (B)(6) (TB-0520FCS, 28K), (B)(6)(TB-0520FCS, 28K), (B)(6)(TB-0520FCS, 29K). THIS MEDWATCH IS FOR THE PATIENT IDENTIFIER (B)(6). DUE DILIGENCE HAS BEEN PERFORMED FOR THIS EVENT. HOWEVER, CUSTOMER DOES NOT HAVE ANY DETAILS OF THE EVENT AVAILABLE AT THIS TIME. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIVING ADDITIONAL INFORMATION.
ADDENDUM (B)(6) 2023: THE PROCEDURE WAS DIAGNOSTIC LIVER RESECTION. THE EVENT OCCURRED WITHIN 10 MINUTES OF THE DEVICE BEING USED. THE ISSUE WITH THE DEVICE WAS EVIDENT INTERMITTENTLY. THE DEVICE FAILED IN THE PATIENT, HOWEVER, THERE WERE NO BROKEN PARTS THAT FELL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. THERE IS NO ADVERSE IMPACT OR HARM TO THE PATIENT NOR WAS ANY EXTENDED HOSPITAL STAY REQUIRED DUE TO THIS EVENT. PATIENT¿S CURRENT STATUS IS FINE. THE INTELLIGENT TISSUE MONITORING (ITM) SETTING WAS ON DURING THE PROCEDURE AS WAS THE USUAL PRACTICE. THE ITM SETTING WAS NOT CHANGED DURING THE PROCEDURE. THE USER UNDERSTANDS THAT THE CHARACTERISTIC OF ITM FUNCTIONALITY, WHICH IS THAT ITM US A SUPPORT FUNCTIONALITY AND MAY NOT NECESSARILY IDENTIFY THAT A TISSUE HAS BEEN CUT ALREADY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ANOMALY NOTED. USER IS A REGULAR USER OF THE DEVICE. NO OLYMPUS REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. USER BELIEVES THAT THE EVENT OCCURRED DUE TO THE DEVICE MANUFACTURING ISSUE.
AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THE DEVICE TEFLON PAD WAS DETACHED. THERE IS NO REPORTED HARM TO ANY PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517129 | THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S | ULTRASONIC SURGICAL DEVICE | GEI | AOMORI OLYMPUS CO., LTD. | TB-0535FCS | KR251892 | 04953170383540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | USG-400 VER. 2.00 |